Irina Lavrynenko Email & Phone Number

Austin, Texas, United States

San Carlos, CA, United States

Iovance Biotherapeutics is a late-stage oncology company that focuses on the development, manufacturing and commercialization of cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL). In my role, I was responsible for QA Operations and Quality Systems. - Performed QA Operation activities that include product disposition, review of the.

San Carlos, CA

- Reviewed and approved Master Batch Record (MBR) for manufacturing, testing, packaging and associated deviations (DEVs)- Responsible for the timely release/reject clinical lots and issuance of the appropriate release certificates - Developed Standard Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with.

Foster City, CA

Gilead Sciences is a biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. In my role, I was responsible for the following:- Maintained monthly Quality Metrics Program to ensure high.

The Colony, TX

Eclipse Aesthetics is a privately held medical device company that developed its own brand of proprietary products and solutions for physicians in the US and internationally. I was brought on board as a CAPA Consultant to assist with the following: - Managed Corrective Action Preventive Action (CAPA) program at the site- Conducted Root Cause Analysis (RCA).

Irving, TX

- Collected and analyzed data at the monthly Quality Management Review (QMR) Meetings - Conducted risk analysis for the various Quality documents: NCEs, DEVs, CAPAs, Customer Complaints, SCARs- Worked with product development group to develop risk management documents, including Process Failure Mode and Effect Analysis (FMEA) to comply with ISO 14971 (Risk.

Irving, TX

- Responsible for the timely initiation, investigation, implementation, and monitoring of assigned quality reports (CAPAs, NCEs, DEVs, SCARs)- Ensured CAPAs/NCEs root cause investigations and actions are clearly documented and implemented to fulfill regulatory requirements- Led CAPA Review Board Meetings - Led CAPA Investigations team to ensure adequate.

Austin, Texas Area

- Performed daily office administrative tasks, client communication- Responsible for updating and maintaining clients financial portfolios - Processed investment related documents insuring compliance - Created marketing materials and gained its approval as well as distributed to the potential clients - Managed 2 college interns

Master Of Science (M.S.), Mechanical Engineering, 3.8

Bachelor Of Science (B.S.), Mechanical Engineering, 3.8